Calcium Salt Bone Void Filler, Drillable, Non-Screw Augmentation

OIS · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3045

Classification

FDA Product Code: OIS
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 888.3045
Review panel: OR
Medical specialty: Orthopedic
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

Definition

To fill traumatic or surgically-created defects not intrinsic to the stability of the bony structure. It is delivered to the defect and resorbs over time to be replaced by bone. Not for screw augmentation.

Market data

Cleared 510(k) submissions: 1
Registered establishments: 13

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown